Total Laryngectomy Clinical Trial
Official title:
Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial
NCT number | NCT04491487 |
Other study ID # | 3347 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | April 1, 2021 |
Verified date | February 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice. This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 1, 2021 |
Est. primary completion date | February 2, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age 18 years and over; - patients waiting for TL and primary TEP; - patients able and willing to provide written informed consent. Exclusion Criteria: - positive history for psychiatric or psychological disorders, - neurological disorders, - ineligibility for voice prosthesis rehabilitation. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A.Gemelli IRCCS | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of Event Scale-revised | presence of post-traumatic symptoms | Between the fifth and seventh post-operative day (T0) | |
Primary | Impact of Event Scale-revised | presence of post-traumatic symptoms | one month after being discharged from hospital (T1) | |
Primary | Impact of Event Scale-revised | presence of post-traumatic symptoms | three months after being discharged from hospital (T2) | |
Secondary | Psychological Distress Inventory | psychological distress levels | Between the fifth and seventh post-operative day (T0) | |
Secondary | Psychological Distress Inventory | psychological distress levels | one month after being discharged from hospital (T1) | |
Secondary | Psychological Distress Inventory | psychological distress levels | three months after being discharged from hospital (T2) | |
Secondary | Hospital Anxiety and Depression Scale | anxiety and depression levels | Between the fifth and seventh post-operative day (T0) | |
Secondary | Hospital Anxiety and Depression Scale | anxiety and depression levels | one month after being discharged from hospital (T1) | |
Secondary | Hospital Anxiety and Depression Scale | anxiety and depression levels | three months after being discharged from hospital (T2) |
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